Dilapan-S / Dilasoft E-Registry in Induced Abortion

  • Research type

    Research Study

  • Full title

    International Observational E-Registry on the use of Dilapan-S/Dilasoft osmotic dilators in cervical dilation prior to termination of pregnancy

  • IRAS ID

    166840

  • Contact name

    Daniela Gdovinova

  • Contact email

    daniela.gdovinova@medicem.com

  • Sponsor organisation

    MEDICEM International

  • Clinicaltrials.gov Identifier

    NCT02318212

  • Duration of Study in the UK

    0 years, 11 months, 27 days

  • Research summary

    This study is designed to document current clinical use of Dilapan-S or Dilasoft for cervical priming prior to induced abortion with regard to the number of dilators used and duration of insertion of dilators in situ.
    This is an international, multicentre, nonintervention, observational study which involves the collection of data on two CE marked products.
    Informed consent will be obtained from the Patients who are identified for cervical priming and anonymous data will be collected by the research team. These data will be analysed to find out the current common clinical practice of use of
    Dilapan-S and Dilasoft. The main focus of the data analysis will be on the duration of cervical priming and the number of dilators used.

  • REC name

    West Midlands - South Birmingham Research Ethics Committee

  • REC reference

    15/WM/0031

  • Date of REC Opinion

    24 Feb 2015

  • REC opinion

    Unfavourable Opinion